Blogs

Web Shows

Resources

Seizure Drug May Treat Alcoholism

The seizure and migraine medication Topamax shows promisefor treating alcohol dependence, a study shows. But use of the drug for thispurpose is not without controversy.

Alcohol-dependent patients in the University of Virginia study who tookTopamax for three and a half months averaged fewer heavy drinking days overall,fewer drinks per day, and more days of continuous abstinence from drinking thanpatients given placebo treatments.

The study was paid for by Topamax manufacturer Ortho-McNeil Neurologics, andit appears in the Oct. 10 issue of TheJournal of the AmericanMedical Association.

A spokeswoman for Ortho-McNeil tells WebMD that the company will not bepursuing FDA approval for the drug as a treatment for alcohol dependence.

But in a letter to the FDA, the consumer interest group Public Citizenaccused the company of illegally promoting use of the drug for thispurpose.

While doctors can legally prescribe FDA-approved drugs for nonapprovedconditions, it is illegal for the companies that market the drugs to promotethese so-called "off label" uses.

The Public Citizen complaint involved a question-and-answer sheetdistributed to the media before publication of the study, which specificallydiscussed the drug's potential "off label" use for alcoholdependence.

Kara Russell of Ortho-McNeill tells WebMD that the company knew nothingabout the question-and-answer sheet until the Public Citizen letter becamepublic.

"Ortho-McNeil Neurologics does not support any reference to off labeluse of its products and only promotes the use of Topamax in the approvedindication of migraine and epilepsy treatment," Russell says.

(What approaches have you tried toquit drinking ? What has worked best? Discuss it with others on WebMD'sAddiction and Substance Abuse: Support Group board.)

Fewer Drinks and Drinking Days

The study included 371 men and women with alcohol dependence. The men drank35 or more standard alcoholic drinks per week prior to enrollment; the womenhad 28 or more drinks. Participants' ages ranged from 18 to 65 with an averageof around 47.

A standard alcoholic drink was defined as one containing 0.5 ounces ofalcohol, which is found in a 10-ounce regular beer, a 4-ounce glass of wine, or1 ounce of 100-proof liquor.

Study participants were treated with up to 300 milligrams of Topamax a dayor a placebo during the 14-week trial. Both groups had a weekly, 15-minutesession with a health care provider designed to promote adherence totreatment.

Only 5% of the Topamax users and 2.7% of the placebo users reportedattending Alcoholics Anonymous meetings during the study.

Compared with placebo treatment, treatment with Topamax was associated withan 8% greater reduction in the percentage of heavy drinking days during thetrial, the researchers reported.

Researcher Bankole Johnson, MD, PhD, tells WebMD that alcoholics in thetrial who took Topamax went from the equivalent of drinking a bottle and a halfof wine a day to about 3 1/2 glasses of wine.

"I think that is a big difference," he says. "Most people canmanage that amount of alcohol without getting into too much trouble."

The researchers reported that Topamax users had a greater rate of achieving28 or more days of continuous nonheavy drinking during the study and 28 days ofcontinuous abstinence.

But they were also more likely to drop out of the trials due to sideeffects, with 34 doing so in the Topamax group compared with just eight in theplacebo group.

Half of the Topamax users experienced burning or prickling sensations intheir extremities, compared with 20% of placebo-treated patients. Concentrationproblems, loss of appetite, and a distorted sense of taste were also morecommon compared with those taking placebo.

But Johnson says most of these side effects disappear over time. Some o hisalcohol-dependent patients have been taking Topamax for as long as two years,and he says they will likely stay on it.

"I think we are about to see a paradigm shift in the treatment ofalcohol dependence," he says. "This treatment and the other drugtreatments offer people an alternative that they haven't had before."

Drugs to Stop Drinking

Addiction treatment expert Mark L. Willenbring, MD, agrees, but adds thatdrugs should not be seen as a replacement for today's most widely used nondrugtreatments like rehab and Alcoholics Anonymous.

He points out that only 10% to 20% of people with alcohol dependence developthe most severe form of the illness, and only about 12% of allalcohol-dependent people ever receive professional treatment.

Willenbring is director of the treatment and recovery research division ofthe National Institute on Alcohol Abuse and Alcoholism.

"One of the goals of the Institute is to promote research intotreatments for earlier and less severe stages of alcohol dependence," hesays. "These people are struggling, but they don't seek treatment."

The hope, he says, is that within five to 10 years drug treatments willbecome common for the treatment of alcohol dependence, in the same way thatselective serotonin reuptake inhibitor (SSRI) antidepressants are now used totreat depression.

"Some people will do fine with drug treatments alone, but others mayneed more intensive interventions," he says.